Associate Quality Engineer bei Thermo Fisher Scientific

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

The Quality Assurance (QA) Operational Support team helps make sure that everything we produce meets the rules and standards needed for medical devices. We check that our processes follow ISO 13485, which is the main quality standard for our industry.

Our team looks into any issues that happen during production, finds out why they happened, and helps prevent them from happening again. We also train and support other teams so that everyone understands and follows our quality processes.

We help assess risks, drive improvements, and review customer feedback to make our products and processes better. The team also contributes to audits, ensuring that only safe, high-quality products are released to customers.

In short, we’re here to make sure everything we do is right the first time, every time — protecting our customers and the patients who rely on our products!

Position Summary: 

The Associate Quality Engineer will be responsible for creating and maintaining quality documentation, developing SOPs, and ensuring compliance with industry and regulatory standards. The role involves managing quality records, reviewing and improving systems and processes, and providing quality guidance for product, process and supplier failure investigations. Additionally, the role includes managing the approval process for artwork changes and supporting artwork activities as part of a global artwork management team.

Responsibilities:

• Create and maintain quality documentation and develop SOPs for the facility, products, and suppliers in line with industry and regulatory standards.

• Create and maintain accurate quality records for all elements of the Quality Management System for Operations and Supplier focus.

• Proactively review and improve systems and processes to ensure maintenance of standards.

• Provide Quality guidance to product, process and supplier failure investigations and in-process controls.

• Assure that Operation's standards align with division and departmental policies.

• Support and administration activities of the eQMS.

• Design and manage local and divisional artwork.

• Coordinate artwork approval process for packaging components ensuring compliance with regulations and originator requirements.

• Manage and maintain artwork trackers, databases, and systems.

• Act as SME for artwork administration in project teams, assist in the management of artwork projects (as appropriate).

• Update artwork files as directed by approved change documentation.

• Liaise with Regulatory Affairs, QA, and Marketing for artwork content guidance.

• Approve artwork proofs from third-party suppliers.

• Support the Regulatory team with the management of technical files supplying approved artwork.

• Work with manufacturing for the management of in-house generated artwork.

• Implement supporting tasks related to artwork projects such as CLP, UDI, and re-branding of products.

• Assist Operations in troubleshooting process issues and facilitate inter-department team workshops in the resolution of process issues and quality problems relating to artwork.

Requirements/Qualifications:

• Bachelor's or Master’s degree or equivalent and relevant formal academic / vocational qualification, graduate applicants are encouraged to apply.

• Experience in a regulated industry (preferable).

• Demonstrated working knowledge of compliance and quality.

• Strong oral and written communication skills.

• Must be a self-starter who can take general concepts and direction and produce desirable results.

• Ability to prioritize multiple tasks and functions effectively in a global, multi-site organization.

• Demonstrated ability to work effectively as a member of a cross-functional team.

Benefits: We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific provides employment with an innovative, forward-thinking organization and outstanding career and development prospects. Join us for an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Ready to make a difference? Apply now and be part of our team!

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